A deployable structure with electrodes mounted on the surface of an endoscopic-guided laser ablation catheter used for ablation and electrophysiological mapping.

Abstract

This invention provides atrial fibrillation ablation using a device that includes a deployable structure with electrodes on the surface of an endoscopic-guided laser ablation catheter. [Solution] A method for ablating target tissue comprises the following steps: (a) supplying an ablation balloon catheter to the target tissue, the ablation balloon catheter comprising a compliant balloon, a visualization device, and an electrode array visible from the visualization device, wherein each electrode 5 is configured to supply ablation energy, and the electrode array is independently movable relative to the compliant balloon; (b) isolating the target tissue so that at least one electrode of the electrode array is in contact with the target tissue; and (c) using the visualization device to supply ablation energy to the electrodes of the electrode array that have been confirmed to be in contact with the target tissue.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority and benefit under 35 U.S.C. § 119(e) to U.S. Patent Application No. 63 / 169,437, filed on April 1, 2021; U.S. Patent Application No. 63 / 238,821, filed on August 31, 2021; U.S. Patent Application No. 63 / 312,684, filed on February 22, 2022; and U.S. Patent Application No. 63 / 314,010, filed on February 25, 2022, each of which is hereby expressly incorporated by reference in its entirety.

[0002] The present disclosure is directed to ablation of atrial fibrillation, specifically ablation of atrial fibrillation using a device that includes a deployable structure having electrodes provided on a surface of an endoscopic - guided laser - ablation catheter for use in ablation and electrophysiological mapping.

Background Art

[0003] Balloon catheters configured to perform ablation of atrial fibrillation are well - known and are described in U.S. Patent No. US9421066B2 to Melsky et al and US9033961B2 to Melsky et al, each of which is hereby expressly incorporated by reference in its entirety. The aforementioned patents treat atrial fibrillation by using an energy source to create non - conductive damage to atrial tissue, such that a circumferential ring of damage is formed in the region of the left atrium where the pulmonary veins join the atrium. Such a circumferential lesion blocks the entry of electrical signals from the veins into the atrium and vice versa. Blocking the passage of such electrical signals can, in most cases, restore the sinus rhythm of the previously fibrillating left atrium.

[0004] Typically, ablation for atrial fibrillation involves introducing an ablation catheter into the left atrium, creating a circumferential injury around the pulmonary veins, and then verifying that the circumferential injury is properly created to effectively block electrical signals. This verification process generally involves removing the ablation catheter, then introducing a catheter with multiple electrodes that may be placed in the pulmonary veins distal to the circumferential injury, and then using these electrodes to monitor the electrograms emanating from the pulmonary veins. When the veins are electrically isolated from the atrium, they are still, and only distant-field electrical activity is observed within them. Occasionally, spikes may occur within the veins, but these do not propagate to the rest of the atrium. By pacing the atria via a catheter with electrodes placed in the coronary sinuses, it can be confirmed that only distant-field activity and random spikes are observed within the veins.

[0005] Here, while the aforementioned devices in Melsky et al.'s US9421066B2 and Melsky et al.'s US9033961B2 are effective ablation devices, like many other ablation devices, they do not include means for quickly and easily confirming electrical isolation after the venous ablation is complete. It is highly desirable to be able to ablate a vein and then confirm that the desired electrical isolation of the vein has been achieved as a result of the ablation without the need to change the catheter. Therefore, one object of the present invention is to provide an ablation device that provides endoscopic-guided laser ablation and means for confirming that electrical isolation of the pulmonary vein has been achieved and for performing such confirmation without the need to remove or change the catheter. Incorrect catheter change carries the risk of introducing air into the left atrium. If air is introduced into the left atrium, it can lead to damage to the brain or heart, and in the case of other organs, the air will move into the capillary bed of the organ and obstruct blood flow there. For this reason, catheter changes are always performed slowly and carefully to minimize the risk of air introduction. However, slowly and carefully changing the catheter increases the time it takes to complete the ablation procedure. Since prolonged procedures pose other risks to the patient and increase the cost of the procedure, it is desirable to reduce the number of catheter changes during the procedure.

[0006] In addition to ensuring that electrical isolation of the veins is achieved, adding electrodes to the ablation catheter as described in Melsky et al. US9421066B2 and Melsky et al. US9033961B2 also enables the delivery of ablation energy that requires a conductive path from the energy source to the ablation area. The delivered ablation energy may be radiofrequency energy or electroporation energy (also known as pulsed-field ablation energy), or other energy such as laser or microwave. The ability to deliver these other types of ablation energy may be desirable when anatomical considerations favor one type of energy over the other. For example, laser energy is desirable because it creates damage that penetrates the entire thickness of the atrial wall, and therefore the electrical dissociation caused by damage created using laser energy is reliably robust and durable. However, in situations where the esophagus is in contact with the left atrium to an extent that ablation is unavoidable, it may be desirable to use electroporation energy in that particular area. This is because the electroporation energy causes damage to cardiac tissue and esophageal tissue in different ways, which opens up the possibility of safely ablating cardiac tissue adjacent to the esophagus by electroporation. In this case, it is proposed that there is no need to closely monitor the temperature of the esophagus, and that there is no need to stop the ablation even if the temperature of the esophagus rises too high. [Overview of the Initiative]

[0007] In summary, one object of the present disclosure is to provide a means for rapidly and easily confirming the electrical isolation of pulmonary veins isolated by endoscopic-guided laser ablation using a device similar to those described in Melsky et al. US9421066B2 and Melsky et al. US9033961B2. A further object of the present invention is to provide such a means in a manner that does not require catheter exchange. A further object of the present invention is to provide both a means for confirming isolation and a means for supplying other forms of ablation energy that can be supplied via an electrode that is either in contact with or adjacent to the tissue. A further object of the present invention is to provide an electrode for either isolation confirmation or ablation that can be endoscopically visualized using an endoscopic device already present in Melsky et al. US9421066B2 and Melsky et al. US9033961B2.

[0008] In an exemplary embodiment, a method for ablating target tissue includes the steps of: supplying an ablation balloon catheter to the target tissue, the ablation balloon catheter comprising a compliant balloon, a visualization device, and an electrode array visible from the visualization device, each electrode configured to supply ablation energy, and the electrode array being independently movable relative to the compliant balloon; isolating the target tissue such that at least one electrode of the electrode array is in contact with the target tissue; and using the visualization device, supplying ablation energy to the electrodes of the electrode array that have been confirmed to be in contact with the target tissue. [Brief explanation of the drawing]

[0009] [Figure 1] This figure shows an exemplary device of the present disclosure in a deployed state, which is deployed on the surface of the inflated balloon of an exemplary balloon catheter. [Figure 2]Figure 1 shows the device in its retracted state, ready to advance along the deflated balloon of the balloon catheter. [Figure 3] Figure 1 shows the device in a certain state, where the device is advanced on the inflated balloon of the balloon catheter and is in a partially deployed state, which is achieved by the inflation of the balloon. [Figure 4] This is a diagram showing a basket for attaching PFA catheters. [Figure 5] This figure shows an electrode catheter for use with a balloon catheter. [Figure 6] This figure shows a dual transseptal / second catheter device, including the electrode catheter shown in Figure 5, positioned on a balloon catheter. [Figure 7] This figure shows an embodiment of a retractable pointed electrode array. [Figure 8] Figures A through C show various states of a retractable pointed electrode array. [Figure 9] This figure shows a balloon catheter with a PFA braided wire mesh electrode array. [Figure 10] This figure shows a balloon with an implantable electrode array. [Figure 11] This figure shows a balloon catheter with micropores and an internal electrode array. [Figure 12] This figure shows a balloon catheter with micropores and an internal electrode array. [Figure 13] This figure shows another balloon catheter having micropores and an internal electrode array. [Figure 14] This is a block diagram showing exemplary components of the endoscopic-guided cardiac ablation system according to the present invention. [Modes for carrying out the invention]

[0010] Figure 1 shows exemplary balloon catheters, such as those described in Melsky et al. US9421066B2 and Melsky et al. US9033961B2, each of which is incorporated by reference.

[0011] Exemplary ablation system Figure 14 is an exemplary schematic block diagram showing an ablation / endoscopic system according to the present invention, designated as a whole by reference numeral 10. The ablation system 10 preferably includes a therapeutic ablation instrument (such as one of those described herein), which preferably includes an endoscope and an ablation device as described below.

[0012] The ablation system 10 more preferably includes a targeting light source 20 and an illumination light source 24. The processor 12 is designed to receive input and output data from connected devices, a display 14, and a controller 16, and to process that data into visual information.

[0013] As can be understood from the following description, it is preferable that the endoscope is provided on the ablation device 100 and has both the function of acquiring live images and the function of recording still images. Illumination light 24 is used to provide surgical light to the treatment site. The illumination light is of a frequency that allows the user to identify the various tissues present at the surgical site. A targeting light source 20 is used to visualize where energy is supplied to the tissue by the ablation device 100. The targeting light 20 is intended to be of a wavelength that can be recorded by an image acquisition device and is visible on a display.

[0014] The processor 12 may be designed to process live visual data, as well as data from the ablation instrument controller and display. The processor 12 is configured to run a set of software and / or hardware modules configured to interpret, manipulate, and record visual information received from the treatment site. The processor 12 may also be configured to manipulate exemplary and illustrative overlays, and composite or hybrid visual data, and provide them to the display device.

[0015] As shown in Figure 14, the system 10 further includes a controller 16, an energy source 18, a targeting light source 20, and a user interface 22. The controller 16 is preferably configured to control the output of the energy source 18, as well as the illumination light source 24 and excitation source 25 of the energy transmitter, and to determine the distance and movement of the energy transmitter relative to the tissue at the ablation treatment site (as further described below). Also, as can be understood from the following description, the endoscope is preferably supported by the ablation instrument and takes images that can be processed by the processor 12 to determine whether a sufficient supply of ablation energy has been directed to a specific area of ​​the treatment site. The data obtained from the endoscope includes real-time video or still images of the treatment site as seen from the ablation instrument. As described herein, these images / videos can be stored in memory for later use.

[0016] Using the aiming light source 20, visualize the position of the treatment site where the ablation instrument supplies energy to the target tissue. Preferably, the aiming light source 20 outputs light in the visible region of the electromagnetic spectrum. When an appropriate ablation path is visible to the user, the controller 16 can transmit radiant energy from the ablation instrument to the target tissue site via the energy source 18, causing ablation by damage. It should be understood that the term "radiant energy" as used herein is intended to encompass energy sources that do not primarily rely on conductive or convective heat transfer. Such sources include, but are not limited to, acoustic sources, laser sources, electroporation energy sources, and electromagnetic radiation sources, and more specifically, microwave sources, X-ray sources, gamma-ray sources, ultrasound, and radiant light sources. Further, the term "light" as used herein is intended to encompass electromagnetic radiation including, but not limited to, visible light, infrared radiation, and ultraviolet radiation.

[0017] The illumination light source 24 is a light source used to provide appropriate illumination to the treatment site. This illumination is configured such that the operator can easily distinguish natural biological color tones and hues.

[0018] The controller 16 can provide the user with the ability to control the functions of the aiming light source, the user input device, and the ablation instrument. The controller 16 functions as the main control interface for the ablation system. By the controller 16, the user can turn on and off both the aiming light 20 and the illumination light 24. Further, the controller 16 has the function of changing the intensities of the illumination light and the aiming light. The function of switching the user interface or the display device is also contemplated. Further, the controller 16 provides access to the ablation instrument, including control of the intensity of the discharge and the duration and position of the ablation energy release. The controller 16 can further provide a safety shut-off to the system if a clear transmission path between the radiation energy source and the target tissue is lost during energy supply (see, e.g., U.S. Patent Application No. 12 / 896,010, filed Oct. 1, 2010, commonly owned by the assignee and incorporated herein by reference in its entirety).

[0019] The controller can be a separate microprocessor-based control interface hardware or can be part of a module configured to operate by a processor-based computer system configured to receive inputs from various physical devices and control them.

[0020] Pulsed electric field ablation energy While the field of pulsed electric fields for histotherapy continues to evolve, it is generally understood that applying a short-duration high DC voltage to tissue can generate a localized high electric field, typically in the range of several hundred volts / centimeter, which disrupts the cell membrane by creating pores. Although the precise mechanism of this electrically driven pore generation or electroperforation is still under investigation, it is believed that applying a large electric field for a relatively short time causes instability in the lipid bilayer of the cell membrane, leading to a distribution of localized cracks or pores in the cell membrane. If the electric field applied to the membrane is greater than the threshold, and the pores remain open instead of closing, this electroperforation can be irreversible, allowing for the exchange of biomolecular substances across the membrane, leading to necrosis and / or apoptosis (cell death). Subsequently, the surrounding tissue may spontaneously heal.

[0021] Generally, a system for supplying a pulsed waveform to tissue (such as those described herein) includes a signal generator configured to generate a pulsed waveform and an ablation device coupled to the signal generator and configured to receive the pulsed waveform. In some embodiments, the ablation device is configured to generate an electric field intensity between about 200 V / cm and about 1500 V / cm. Thus, a system for ablating tissue described herein can drive electroporation by including a signal generator and an ablation device having one or more electrodes and an expandable / inflatable member (e.g., a balloon) for selectively and rapidly applying a DC voltage.

[0022] In some embodiments, the voltage pulse waveforms disclosed herein may be hierarchical or have a nested structure.

[0023] The irreversible electroporation systems described herein may include a processor and a signal generator configured to apply one or more voltage pulse waveforms to a pair of electrodes to supply energy to a region of interest. To supply the pulse waveforms generated by the signal generator, in at least one embodiment, one or more electrodes of the ablation device may have insulated electrical leads configured to maintain a potential of at least about 2500 V without dielectric breakdown of the corresponding insulator. In some embodiments, at least some of the electrodes may be independently addressable so that each electrode is controlled (e.g., supplies energy) independently of any other electrodes of the device.

[0024] As shown in Figure 14, the system may include a signal generator 29 configured to generate pulse waveforms for irreversible electroperforation of tissue, such as pulmonary veins. For example, the signal generator 29 may be a voltage pulse waveform generator and configured to supply pulse waveforms to one of the ablation devices (ablation instruments) described herein. The processor 12 can incorporate data received from memory to determine the parameters of the pulse waveform generated by the signal generator 29, while some parameters, such as voltage, can be input by the user. The memory may further store instructions for the signal generator 29 to execute modules, processes, and / or functions related to the system, such as pulse waveforms. For example, the memory may be configured to store pulse waveforms for the generation of pulse waveforms.

[0025] Some embodiments involve pulsed high-voltage waveforms along with an ordered supply scheme for delivering energy to tissue via multiple sets of electrodes. The signal generator and processor can be configured to apply pulsed voltage waveforms to a selection of electrodes or a subset of electrodes from among the electrodes of the ablation device.

[0026] In one application, the pulse voltage waveform can take the form of a series of double pulses, each having a pulse associated with a pulse width or pulse duration. The pulse width / duration can be approximately 0.5 microseconds, approximately 1 microsecond, approximately 5 microseconds, approximately 10 microseconds, approximately 25 microseconds, approximately 50 microseconds, approximately 100 microseconds, approximately 125 microseconds, approximately 140 microseconds, and approximately 150 microseconds (including all values ​​and subranges in between). The pulse waveform can be defined by a set of single-phase pulses in which all pulses have the same polarity (e.g., all are positive when measured from a zero baseline). In some embodiments, such as irreversible electroporation applications, the height or voltage amplitude of each pulse can range from approximately 400 volts, approximately 1,000 volts, approximately 5,000 volts, approximately 10,000 volts, and approximately 15,000 volts (including all values ​​and subranges in between) (e.g., in one application, a maximum amplitude of 2,500 volts is used). Pulses are separated from adjacent pulses by a time interval sometimes called the first time interval. To generate irreversible electroporation, the first time interval can, for example, be about 1 microsecond, about 50 microseconds, about 100 microseconds, about 200 microseconds, about 500 microseconds, about 800 microseconds, or about 1 millisecond (including all values ​​and subranges in between). It will be understood that the values ​​described above are essentially illustrative and do not limit the scope of the invention, as values ​​outside the aforementioned ranges may exist in other applications.

[0027] Exemplary ablation catheter As shown in Figures 1 to 3, one exemplary ablation device concerns an overall flexible elongated structure 1 slidably positioned on the elongated shaft 2 of a balloon ablation catheter. The elongated structure 1 can be thought of as a sleeve that is displaceable longitudinally on the balloon catheter. While the term “elongated structure” is used herein, it will be understood that the term “sleeve” can be used interchangeably therewith. As described herein, the elongated structure 1 can move along the balloon catheter to cover different regions of the balloon catheter. As described herein, the elongated structure 1 is configured to respond to the movement of the balloon ablation catheter, more specifically, to the stretching and contraction of the balloon when the elongated structure covers the balloon at least partially.

[0028] The elongated structure 1 generally has several distinct parts, which include a proximal and a distal portion. The proximal portion of the elongated structure 1 comprises a first tubular portion 3, as shown in Figure 1. This proximal region is spaced 2 to 4 cm back from the distal end. However, this is merely an illustrative value and does not limit the scope of the invention. The first tubular portion 3 is configured such that the shaft 2 of the balloon ablation catheter passes through its lumen. In other words, the first tubular portion 3 completely surrounds the catheter shaft 2 in at least one region of the first tubular portion 3.

[0029] The first tubular portion 3 may be formed from a flexible material.

[0030] The distal portion of the elongated structure 1 is multi-branched into two or more, preferably six or more, branches 4, which are also flexible. Each branch 4 includes one or more electrodes 5 on its outward-facing surface. Each electrode 5 is connected to an insulated conductor embedded in the body of the elongated flexible structure 1, although such conductors are not shown in Figure 1. For example, the structure 1 can be overmolded onto a conductor. As shown, when multiple electrodes 5 are used for each branch 4, the electrodes 5 are spaced apart longitudinally along each branch 4. It will be understood that the electrodes 5 can be of the same type or of different types. In other words, the electrodes 5 can be of different sizes and / or different shapes. The arrangement of the electrodes 5 can be asymmetrical in that the electrodes 5 can be concentrated in one or more regions of the branch 4. For example, the electrodes 5 can be positioned more centrally and distally along the branch 4, as opposed to being positioned proximal.

[0031] Therefore, the branches 4 can be spaced apart from each other in the circumferential direction and extend circumferentially around the balloon. It is also possible to design the branches 4 to have an asymmetrical appearance, in that instead of having symmetrical angular displacements between the branches 4, an asymmetrical arrangement can be provided. In other words, the branches 4 can have a certain type of angular displacement within one half of the elongated structure 1 and a different type of angular displacement within the other half. In other words, there may be more branches 4 in one half of the structure 1 compared to the other half of the structure 1. For example, the first half of the circumference may have a first number of electrodes, while the second half of the circumference may have a second number of electrodes different from the first number.

[0032] As shown in the figure, each branch 4 has a first end (proximal end) and a second end (distal end) on the opposite side. The first end of branch 4 is attached to the first tubular portion 3, and in one embodiment, branch 4 is formed integrally with the first tubular portion 3.

[0033] Multiple flexible branches 4 rejoin at their second ends to form a second tubular structure 6 at the distal end of the elongated structure 1. The second tubular structure 6 surrounds the distal tip 7 of the balloon ablation catheter in a manner that allows it to slide (both axially and rotationally).

[0034] When the elongated structure is positioned over at least a portion of the balloon, the branching (branch 4) generally forms an expandable cage-like structure that circumferentially surrounds the inflated balloon 8. The proximal portion of the elongated structure 1 can maintain a tubular shape proximal to the rear branching (branch 4), or alternatively, the proximal portion of the elongated structure 1 may consist only of a partial circumferential portion of the tube, as shown in 9, thereby being more flexible and occupying less volume than if it were a complete tube. A shaft 2 can be seen between the multiple portions of the elongated structure 1.

[0035] It will be understood that the device 1 is preferably formed as a single elongated structure in which the tubular portion 3, the tubular portion 6, and the branch 4 positioned between them are formed as a single integrated part (e.g., a molded part).

[0036] Figure 2 shows the movement of the elongated structure 1 on a balloon catheter. More specifically, the first tubular portion 3 and branch 4 are shown in a relaxed state. This represents the normal resting state of the elongated structure 1. It is evident from this state that such a structure can be manufactured by creating a series of longitudinal slits 10 in a generally thin, flat material formed into a tubular shape. In other words, branch 4 is formed by incorporating longitudinal slits into the structure 1 such that one branch is defined between two adjacent slits. A suitable thin, flat material would be polyimide film, such as that commonly used to manufacture flexible printed circuits or flex circuits. It will be understood that other materials are equally possible.

[0037] Figures 1 and 2 both illustrate how the device achieves the objective of providing a means to enable pulmonary vein isolation using a balloon catheter guided by an endoscope, and additionally providing a means to confirm electrical isolation of veins without the need for catheter replacement, which is required in the prior art. As will be described in more detail below, the inner surface of the tubular structure may include markings visible from the endoscope to indicate the position of the electrodes.

[0038] Therefore, there may be two defined surgical stages, including a first stage, which is the ablation stage of the procedure, in which the elongated structure 1 is not used. During this ablation stage, the elongated structure 1 is in a deflated state, located proximal to the balloon of the balloon catheter and tightly surrounding the shaft 2 of the balloon catheter, as shown in Figure 2. As shown in this stage and state, the entire elongated structure 1 is displaced from the balloon of the balloon catheter and positioned proximal to the balloon. Thus, the distal second tubular shaft portion 6 is positioned proximal to the balloon.

[0039] In this state (first stage), the elongated structure 1 allows the ablation catheter balloon to be inflated and positioned within the pulmonary vein, without obstruction throughout. The vein may be visualized endoscopically by the ablation catheter, and laser energy may be supplied to the vein, regardless of the present invention. In other words, as in the applicant's previous ablation catheter designs, the energy from the movable energy emitter 0 (Figure 2) present within the balloon passes through the balloon and reaches the target site without any obstruction from the elongated structure 1. This is because the elongated structure 1 is spaced apart from and not in contact with the inflated range of motion of the balloon.

[0040] This is not true if the electrodes (such as electrode 5) are placed directly on the surface of the balloon, because such electrodes block both the laser energy and endoscopic visualization passing through the portion of the balloon in which they are located.

[0041] Once venous ablation (stage 1) is achieved, the balloon of the ablation catheter is deflated, but the elongated structure 1 of the ablation catheter is not repositioned relative to the vein. With the ablation catheter structure stationary relative to the ablated vein, the elongated structure 1 advances distally along the deflated balloon. The balloon is then reinflated, and such reinflation stretches the branches (multi-branchs) 4 of the elongated structure 1, forcing at least several electrodes 5 into contact with the lumen of the vein. At this point, the electrodes 5 can be used to confirm electrical isolation. For this purpose, a wire connected to the electrodes 5 and extending proximal along the proximal portion of the elongated structure 1 until it emerges outside the patient's body is connected to a known device. This known device can amplify and display the electrical activity emitted from the tissue in contact with the electrodes 5.

[0042] It should also be noted that when electrode 5 is in contact with pulmonary venous tissue (or other target tissue), it is also possible to supply ablation energy, such as radiofrequency energy, electroporation energy, or microwave energy, by connecting a source of ablation energy to a wire attached to the electrode. It should also be noted that the electrode position is visible from an endoscope 50 (Figure 2) located inside the balloon of the ablation catheter. This visibility is achieved either by creating a multi-branch 4 from a transparent material, or by creating a mark on the inner surface of the multi-branch directly adjacent to the electrode position. Such visualization of the endoscopic electrode position allows for a visual assessment of the state of contact between the electrode and the tissue. For example, a given electrode may be in firm contact with venous tissue throughout the entire cardiac cycle. Alternatively, electrode 5 may be in contact with tissue for a portion of the cardiac cycle and not in contact with tissue for the rest of the cardiac cycle, but instead in contact with blood, or the electrode may not be in contact with tissue for any portion of the cardiac cycle. Such a visual assessment of the nature of contact between tissue and electrode is not currently available in any known device. Such evaluations help in interpreting electrograms measured by electrodes. Furthermore, when electrodes are used for the purpose of applying radiofrequency, electroporation, or microwave ablation energy, such visual information regarding the degree of tissue contact can be used to determine which of several electrodes is suitable for supplying ablation energy, based on the degree of tissue contact they provide. Also, if deemed necessary to better evaluate electrical activity within the vein or to obtain better electrode contact and enable ablation by applying radiofrequency or electroporation energy, endoscopic images can be used to guide the repositioning of the balloon within the vein to improve contact between the electrode and venous tissue.

[0043] Sliding action of the elongated structure 1 As described herein and shown in Figures 1-3, the elongated structure 1 is configured to move longitudinally along a balloon catheter. It is also configured to have rotational motion relative to the balloon. The elongated structure 1 can be manually moved by grasping one end of it (e.g., the first tubular portion 3) and moving the entire structure 1 longitudinally distally or proximal. Alternatively, the elongated structure 1 can be moved proximal by grasping the first tubular portion 3 and pulling it proximal. Preferably, the first tubular portion 3 extends proximal out of the body to a point where it can be directly grasped and used by the user. To assist the user in moving the structure 1, the most proximal end of the structure 1 may have a gripping feature, such as an expanding ring section at the proximal end of the first tubular portion 3. Alternatively, a surface texture, etc., may be provided on one or more areas of the first tubular portion 3.

[0044] As the elongated structure 1 is retracted and moves proximal, it can enter the lumen formed within the catheter structure, or the lumen of a guiding sheath or deflectable sheath commonly used in atrial ablation procedures, through which the balloon catheter and tubular structure can pass. This means that the tubular structure can be retracted into the catheter shaft or into the guiding sheath or deflectable sheath by sliding it, and this retraction means that the elongated structure 1 deflates and is released from its surrounding relationship around the balloon. When the structure 1 is retracted into the lumen of the catheter shaft, the branches deflate and become compact. It should be noted that when the tubular structure is retracted into the guiding sheath or deflectable sheath, the multi-branched structure of the tubular structure is supported by the inner surface of such sheath and is prevented from stretching or bending outward, and also from bending inward by the shaft of the balloon catheter. In such a state, the tubular structure is prevented from stretching or contracting and is therefore more easily repositioned relative to the balloon catheter. In the case of a device where only the ablation energy employed is supplied via electrodes, it is not necessarily required to retract the elongated structure to a position completely proximal to the balloon. In other words, the elongated structure 1 is movable between several positions, one of which is a position where at least some electrodes cover the balloon at least partially.

[0045] Controllable electrodes The entire ablation system described herein, including the elongated structure 1 and the ablation balloon catheter, can communicate through a network with various machines configured to transmit and receive content, data, and instructions, and the execution of these instructions enables the operation of various connected components / mechanisms. The content and data can include information in various forms, including, but not limited to, text, audio, images, and video, as well as embedded information, metadata, and / or machine-executable instructions, such as links to other resources on the network. Each computing device may be in a conventional configuration, and the description will be made with respect to servers that provide various content and services to other devices such as mobile computing devices, but as will be understood by those skilled in the art, one or more server computing devices can be collectively constitute the same machine, or in larger embodiments they can be distributed across several machines. In the relevant parts, each computer server has one or more processors, computer-readable memory that stores code that configures the processors to perform at least one function, and communication ports for connecting to a network. The code can include one or more programs, libraries, functions, or routines, which for the purposes of this specification can be described in terms of multiple modules (resident in representative code / instruction storage) that perform various parts of the process described herein. As described herein, each robotic device (tool) has a controller (processor) and thus constitutes a form of the computing device described above.

[0046] Furthermore, computer programs such as imaging or measurement software (also generally referred to herein as computer-controlled logic or computer-readable program code) can be stored in main memory and / or secondary memory and executed by one or more processors (such as controllers) to cause one or more processors to perform the functions of the present invention as described herein. In this specification, the terms “memory,” “machine-readable medium,” “computer program medium,” and “computer-usable medium” are generally used to refer to media such as random-access memory (RAM), read-only memory (ROM), removable storage units (e.g., magnetic disks or optical disks, flash memory devices, etc.), hard disks, and others. In the case of mobile computing devices (e.g., tablets), it should be understood that computer programs such as imaging software can be in the form of application software that runs on the mobile computing device.

[0047] A system may include a graphical user interface (GUI) provided to enable remote control of the system. As is known, a GUI is a system of interactive visual components for computer software. A GUI displays objects that convey information and represent actions that a user can perform. When a user interacts with an object, the object's color, size, or visibility changes. GUI objects include icons, cursors, and buttons. These graphic elements may be enhanced with sound or visual effects such as transparency and drop shadows.

[0048] A graphical user interface typically includes a display, such as a touchscreen display, which allows user input to be recorded and then executed by a main controller (main processor).

[0049] In one exemplary embodiment, the operation of electrode 5 can be controlled using a main controller. In other words, selected electrodes 5 can be activated at a given time using the main controller. Ablation energy is supplied to the activated electrodes 5, but not to the unactivated electrodes 5. As mentioned, the electrodes 5 can be wired from an electrical connector that is itself connected to a terminal (console) or the like (e.g., an outlet or its plug), thereby supplying power to the electrodes 5.

[0050] Depending on specific parameters such as the position of the balloon catheter within the body, a specific electrode 5 can be activated and turned on, while it is also possible to turn off a specific electrode 5 and keep it inactive. For example, if the balloon catheter and tubular structure are in contact with a specific tissue, and such contact with the tissue is visualized by an endoscope inside the balloon, the user may want only the electrode 5 in contact with the tissue to receive ablation energy. Therefore, the operator can strategically select which branches 4 and electrodes 5 to activate based on the guidance of the endoscope, etc.

[0051] The master controller can communicate with a display that can show images and data.

[0052] The operator can select which branch 4 and electrode 5 to activate (apply voltage to) using a touchscreen or similar device. For example, a graphic image of the elongated structure 1, more specifically, graphic images of branch 4 and electrode 5, can be displayed to the operator, who can then select which branch 4 / electrode 5 to activate. If a touchscreen is used, the operator can simply highlight and select which branch 4 / electrode 5 to activate with their finger. It is also conceivable that AI-based software could be used to determine which electrode should be activated based on whether the electrode is in contact with tissue, and then recommend this to the user.

[0053] PFA catheter mounting basket Figure 4 shows a balloon catheter 100 including a main catheter shaft 110 having a distal end. It will also be understood that the balloon catheter 100 typically includes more than one shaft, often including an inner catheter shaft and an outer catheter shaft, or otherwise including multiple concentric tubular structures. An inflatable balloon 120 is included in and coupled to the main catheter shaft 110, with the distal end of the inflatable balloon 120 close to the distal end of the main catheter shaft 110, and the proximal end of the inflatable balloon 120 spaced away from the distal end. Thus, the inflatable balloon 120 surrounds the main catheter shaft 110.

[0054] Figure 4 also shows the inner shaft 115 together with the endoscope 125. The endoscope 125 extends along the outside of the inner shaft 115 and is oriented forward, typically positioned at one end of the balloon and facing the other end of the balloon forward.

[0055] The inflatable balloon 120 is preferably a compliant balloon.

[0056] The inflatable balloon 120 also includes an endoscope 125 positioned within the compliant balloon. The endoscope allows the catheter operator to visualize the balloon surface and thereby direct the laser energy to the portion of the balloon surface that is in contact with the atrial tissue to be treated with the laser energy. Such systems are described in Melsky et al. (U.S. Patent No. 9,421,066) and Melsky et al. (U.S. Patent No. 9,033,961), each of which is incorporated herein by reference in whole. The endoscope is positioned proximal to the point where energy is supplied to the tissue and allows the user to observe the energy supply and the resulting tissue damage(s). The endoscope may be one of the endoscopes described herein, or one of the endoscopes described in any of the specifications incorporated herein by reference.

[0057] Figure 4 shows the energy emitter 127. However, in embodiments where the electrode array is intended to remain in a position surrounding the inflatable balloon 120, it will be understood that the energy emitter 127 may be excluded or present but never used. If the electrode array can be moved away from the balloon, the energy emitter 127 can be used.

[0058] The endoscope 125 is forward-facing and positioned adjacent to one of the catheter shafts, such as a central tube, which is usually made of a transparent polymer material. As used herein, the term forward-facing refers to the endoscopic view distal to the catheter body. Similarly, the term laterally facing refers to the endoscopic view in a direction radially outward from the side of the catheter body.

[0059] The endoscope 125 can be a fiber optic endoscope that is inserted through the lumen of the catheter and positioned within the proximal region of an inflatable balloon 120.

[0060] In another embodiment, the ablation catheter 100 includes first and second imaging devices that provide direct visualization of the treatment area, the first imaging device being fixed to the catheter body. The first and second imaging devices may be in the form of first and second imaging tip endoscopes. Details of the first and second imaging tip endoscopes are described in U.S. Patent Application No. 17 / 524,472, which is expressly incorporated herein by reference in its entirety.

[0061] The balloon catheter 100 includes an expandable basket 130, which surrounds an inflatable balloon 120 and is configured to expand simultaneously with the expansion (inflation) of the inflatable balloon 120, and similarly to contract simultaneously with the contraction and deflating of the inflatable balloon 120. The expandable basket 130 has a first collar (first ring) 132 at its first (proximal) end and a second collar (second ring) 134 at its second (distal) end. The first and second collars 132 and 134 have annular shapes and can therefore form a continuous ring shape. The sizes of the two collars 132 and 134 may differ from each other, and in the illustrated embodiment, the first collar 132 is larger than the second collar 134. The two collars 132 and 134 are sized and configured to securely connect the expandable basket 130 to the main catheter shaft 110 (or one or more other catheter shafts) with the inflatable balloon 120 positioned between the two collars 132 and 134. Therefore, the first collar 132 is preferably positioned proximal to the inflatable balloon 120, while the second collar 134 is positioned distal to the inflatable balloon 120.

[0062] The expandable basket 130 includes a plurality of splines 140 attached to a first collar 132 at one end and to a second collar 134 at the other end. The plurality of splines 140 extend longitudinally along the length of the inflatable balloon 120. The plurality of splines 140 are offset from each other in the circumferential direction, and open spaces are formed between adjacent splines 140. The splines 140 are constructed to expand and contract under the action of the inflatable balloon 120 below. In particular, when the inflatable balloon 120 expands under inflation, the splines 140 expand outward, and conversely, when the inflatable balloon 120 contracts under deflation, the splines 140 contract inward. Thus, the splines 140 conform to the shape of the inflatable balloon 120.

[0063] Each spline 140 carries one or more electrodes 150. For example, each spline 140 may include multiple electrodes 150, which may be described as an electrode array. In the illustrated embodiment, there are three electrodes 150 arranged along the length of the spline 140. The electrodes 150 are spaced apart longitudinally (in series) along the spline. Thus, the electrodes 150 are spaced apart from each other at a predetermined set distance. The position of the spline 140 along the spline 140 is chosen to center the electrodes 150 relative to the inflatable balloon 120, because when the inflatable balloon 120 inflates, the electrodes 150 are positioned toward the target tissue to be ablated using the PFA technique as described herein.

[0064] The electrodes 150 defining the electrodes can be of the same electrode type or of different types. For example, as shown in the figure, multiple electrodes 150 can be the same shape and size. The material of the expandable basket 130 is not elastic in that the splines are not elastically stretched in the longitudinal direction, but it can be stretched and contracted together with the inflatable balloon 120 below. Therefore, the longitudinal spacing between the electrodes 150 does not change when the expandable basket 130 moves between an extended position and a retracted position. Instead, a fixed distance is important, and this information is used during the visualization and ablation process to form the desired damage, as described herein.

[0065] In comparison with the embodiments shown in Figures 1 to 3, Figure 4 shows a product in which an expandable basket 130 is fixed in at least one embodiment.

[0066] In yet another aspect of this disclosure, the system may include electrode markers that mark the position of the electrode 150 along the spline. In particular, the electrode 150 is located on the outer surface of the spline 140, and the spline is typically formed of an opaque material, and therefore the electrode 150 is not visible in the live endoscopic image. Since the spline 140 is typically formed of an opaque material, only the inner surface of the spline 140 is visible from the endoscope 125, and therefore the electrode 150 cannot be seen. Markers can be provided along the inner surface of the spline 140 to determine the position of the electrode 150 during visualization (i.e., use of the endoscope 125). Each marker is placed on the inner surface of the spline 140 on the opposite side of the position of the electrode 150 to mark the position of the electrode 150. The markers can be visually identifiable in the live endoscopic image and therefore may take the form of visual indicia formed along the inner surface of the spline 140. For example, the visual indicia may take the form of digits and / or text indicia. Furthermore, the visual indicia is chosen so that one electrode can be distinguished from another electrode. For example, each spline can be numbered, such as spline 1, and then each electrode 150 can be numbered, such as A, B, C. Thus, in the illustrated embodiment, the most distal electrode of spline 1 can be identified by marker 1A, the central electrode by marker 1B, and the most proximal electrode by marker 1C. Similarly, for the adjacent spline 2, the markers can be 2A, 2B, and 2C. It will be understood that there are many different ways to visually distinguish one electrode on one spline from another electrode on another spline.

[0067] For example, color can be used to distinguish one spline 140 from others. For instance, the letters A, B, C, or the numbers 1, 2, 3 could be colored differently in one spline than in another. Symbols can also be used as markers.

[0068] Since not all electrodes 150 are in the desired contact with the target tissue, not all electrodes are visible in the live endoscopic image. Therefore, it is important to understand which electrodes are visible in the live endoscopic image and in contact with the tissue in order to activate them.

[0069] The movement of the expandable basket 130 and the inflatable balloon 120 may vary depending on the embodiment. For example, in one embodiment, the expandable basket 130 and the inflatable balloon 120 can move together, while in another embodiment, the basket 130 can move independently of the balloon 120. For example, the basket 130 may be fixed in the rotational direction but movable in the axial direction (longitudinal direction), or in another embodiment, it may be fixed.

[0070] The movement of the expandable basket 130 relative to the catheter body and inflatable balloon 120 can be controlled either by an automated process, such as using an electronic controller, or by a manual process performed under user action. This control allows for desired movement in the rotational and / or longitudinal directions.

[0071] Energy supply and electrode selection: In one embodiment, energy is supplied to two or more electrodes 150 arranged along the same spline 140. In this embodiment, the distance between the electrodes 150 on one spline 140 is fixed and does not change based on basket stretching. This makes it possible to select PFA administration since the distance between the electrodes 150 to be activated is known. In another embodiment, energy is supplied between two electrodes 150 arranged along adjacent splines 140, rather than along the same spline 140. In this case, the distance between the splines 140 changes depending on the degree of basket stretching. For example, the greater the degree of basket stretching, the greater the distance between the splines 140, and therefore the greater the distance between the electrodes 150. If the electrode spacing remains fixed, the degree of predictability of administration is greater.

[0072] The (PFA) dosage is selected based on the visualization information, as well as the position and spacing of the electrodes to be activated to induce damage formation. The correct (optimal) dosage provides adequate tissue isolation without adversely affecting tissue quality.

[0073] In tissue ablation, rather than activating all electrodes 150, only specific selected electrodes 150 are activated. Only the electrodes 150 in direct contact with the tissue are activated and supplied with energy, thereby causing tissue damage.

[0074] Depending on the visualization information, it may be necessary to move the basket 130 axially and / or rotationally to perform the ablation. For example, if the electrode spacing is too large, it may be necessary to supply energy to form a first injury segment, then move the basket relative to the balloon (axially and / or rotationally) to reposition the electrodes and supply energy to form a second injury segment that combines with the first injury segment to form a more complete injury segment. Alternatively, the circumferential electrode spacing can be estimated from the endoscopic view, and the PFA administration can be adjusted to compensate for different electrode spacings.

[0075] The shape and size of the formed damaged segments depend on which electrodes are activated and their positions. For example, activating two electrodes 150 located along the same spline 140 results in damage that is more longitudinally extended, while activating two electrodes 150 located along adjacent splines results in damage that is more circumferentially extended.

[0076] Double transseptal / secondary catheter Figures 5 and 6 show a balloon catheter 200 similar to balloon catheter 100, except that balloon catheter 200 does not include an expandable basket 130. Consequently, the reference numbers used in Figure 4 are also used in Figures 5 and 6 for parts common to both embodiments. Inflatable balloons are typically transparent, and therefore Figure 6 shows the transparent nature of the balloon.

[0077] The balloon catheter 200 includes a main catheter shaft 110, which typically includes more than one shaft, often including an inner catheter shaft and an outer catheter shaft, or otherwise including multiple concentric tubular structures as shown. The inflatable compliant balloon 120 is included in and coupled to the main catheter shaft 110, with the distal end of the inflatable balloon 120 close to the distal end of the main catheter shaft 110 and the proximal end of the inflatable balloon 120 spaced apart from the distal end. Thus, the inflatable balloon 120 surrounds the main catheter shaft 110.

[0078] This embodiment includes an electrode catheter 210 for use with a second catheter, i.e., a balloon catheter 200. The electrode catheter 210 comprises an elongated structure having an open distal end and a proximal region 220 and a distal electrode region 230. The proximal region 220 may comprise an elongated, arch-shaped body that is not perfectly circumferential. Conversely, the distal electrode region 230 may be a perfectly circumferential structure. The distal electrode region 230 includes a proximal collar 232 at its proximal end and a distal collar 234 at its distal end. Between the two collars 232, 234, the body of the distal electrode region 230 includes a plurality of longitudinal slits 240 that are spaced circumferentially around the body. These slits 240 define a plurality of longitudinal splines 245. The slits 240 do not extend into the range of the two collars 232, 234. The spline 245, in close resemblance to the spline 140, carries one or more, preferably more electrodes (e.g., electrodes 150), arranged along the outer surface (outer surface) of the spline 245. Each spline 245, in close resemblance to the previous embodiment, can carry more electrodes, such as three of a larger number of electrodes arranged in series and spaced apart from each other in the longitudinal direction of the spline 245.

[0079] Both ends of the distal electrode region 230 are open and therefore represent an open-end tubular structure configured to receive a retracted (deflated) resting balloon catheter, as described herein.

[0080] Similar to previous embodiments, the spline 245 is not elastic and therefore not stretchable, but it can stretch in response to the stretching of the inflatable balloon 120. Thus, the distance between electrodes along the same spline 245 does not change based on whether the spline 245 is stretched or retracted. However, similar to previous embodiments, the distance between two electrodes on two different splines 245 changes based on the degree of stretching.

[0081] The balloon catheter is inserted into the hollow interior (lumen) of the electrode catheter 210, and as it penetrates through it, the spline 245 surrounds the inflatable balloon 130. When the balloon inflates, the spline 245 stretches radially outward and separates from each other.

[0082] As in other embodiments, the spline 245 can be deflated by retracting it into the main (outer) catheter shaft.

[0083] In this embodiment, visualization is also used to determine which electrodes are in contact with the tissue, and visualization can guide the user in terms of making any adjustments with the balloon catheter and / or electrode catheter to form a completely continuous injury.

[0084] Retractable pointed electrode array Figures 7 and 8A-8C show a balloon catheter 300 similar to balloon catheter 100, except that balloon catheter 300 does not include an expandable basket 130. Consequently, the reference numerals used in Figure 4 are also used in Figures 7 and 8A-8C for parts common to both embodiments.

[0085] The balloon catheter 300 includes a main catheter shaft 110, which typically includes more than one shaft, often including an inner catheter shaft and an outer catheter shaft, or otherwise including multiple concentric tubular structures as shown. The inflatable balloon 120 is included in and coupled to the main catheter shaft 110 and / or additional shafts, with the distal end of the inflatable balloon 120 close to the distal end of the main catheter shaft 110 and the proximal end of the inflatable balloon 120 spaced apart from the distal end. Thus, the inflatable balloon 120 surrounds the main catheter shaft 110.

[0086] The balloon catheter 300 further includes a retractable electrode sheath 310 configured to be retracted into the main catheter shaft 110 or another shaft of the catheter. Thus, as described herein, the retractable electrode sheath 310 is designed to move longitudinally along the main catheter shaft 110, and more specifically, the retractable electrode sheath 310 moves within the main catheter shaft 110 so that the retractable electrode sheath 310 moves between a fully retracted position and a fully extended position. In the fully retracted position, at least a substantial length of the retractable electrode sheath 310 is housed within the main catheter shaft 110, and in the fully extended position, a substantial length of the retractable electrode sheath 310 is located outside the main catheter shaft 110 and surrounds the inflatable balloon 120, as described herein. As shown in the figure, in the fully extended position, the apex 320 can be extended to at least 75% of the length of the balloon 130 and can be extended to more than 90% of the length of the balloon. In another embodiment, the tines 320 extend to at least 50% of the length of the balloon 130 (for example, they extend to at least the widest part of the inflated balloon 130).

[0087] The retractable electrode sheath 310 includes a proximal collar 312, which can be a continuous cylindrical structure, and a plurality of extendable ribs 320 integrated with the proximal collar 312 at the proximal end. The ribs 320 are cantilevered in that the distal end of each rib 320 is a free end and is not attached to another structure. When fully extended, the ribs 320 are spaced apart and circumferentially spread around the balloon 130.

[0088] As in other embodiments, the fork 320 is not elastic and is never stretched. However, the fork 320 can stretch outward (radially) as the inflatable balloon 130 inflates, and similarly, the fork 320 can contract as the inflatable balloon 130 deflates. Thus, the fork 320 can conform to the compliant balloon 130.

[0089] To cause the tines 320 to retract and completely deflate, the retractable electrode sheath 310 is pulled back proximal to the main catheter shaft 110. As the retractable electrode sheath 310 enters the main catheter shaft 110, the presence of the main catheter shaft 110 surrounding it applies an inward force to the tines 320. This inward force causes them to deflate, allowing them to move within the main catheter shaft 110 and be retracted away from the balloon 130.

[0090] As shown in these figures, each prism 320 includes one or more electrodes 150, preferably multiple electrodes spaced apart along the prism 320. The electrodes 150 are arranged in series along the length of the prism 320. The electrodes 150 along the prism 320 can be of the same type (e.g., the same shape and size), or in another embodiment, different types of electrodes can be used.

[0091] As in other embodiments, visualization (e.g., endoscopy) can be used to determine which electrodes 150 are in contact with tissue, and then those selected electrodes can be activated to form damage. The user interface enables identification and power supply of the electrodes 150 in contact with tissue. As previously mentioned, the operating software can be programmed to calculate the appropriate dosage based on the distance between the activated electrodes 150 and to supply the necessary energy to the electrodes 150.

[0092] As with all embodiments, it is desirable to limit electrode activation to only those electrodes necessary for forming damage (segments).

[0093] Figure 8A shows the inflatable balloon 130 in a deflated state, with the frustum 320 fully retracted and substantially located within the main catheter shaft 110 (for example, only the tip of the frustum 320 protruding outside the main catheter shaft 110).

[0094] Figure 8B shows the inflatable balloon 130 in a deflated state, while the thorn 320 is deployed. As mentioned, the degree of coverage of the thorn 320 over the balloon 130 can be varied.

[0095] Figure 8C shows the inflated balloon 130, which in turn stretches the deployed tine 320. In this figure, the tine 320 is shown spread to approximately 50% of the length of the balloon 130. However, this is essentially illustrative and it should be understood that it can spread more or less along the length of the balloon.

[0096] Accordingly, the embodiments in Figures 7 and 8A-8C include a semi-rigid retractable prism 320, which is housed within a catheter (main catheter shaft 110) and has one or more electrodes 150 along the outer surface of each prism 320, and is deployed before the balloon 130 is inflated (to this end, a controller (manual or electric) is used to slide the retractable electrode sheath 310 distally). When the balloon 130 is inflated, the electrodes 150 are pressed against the inner surface of the tube, achieving tissue contact. As with other embodiments, this embodiment allows for confirmation of tissue contact and electrode spacing under direct visualization using an endoscope within the balloon 130. Once tissue contact and the desired electrode spacing are confirmed, energy is applied to the desired (selected) electrode 150 to cause damage. This embodiment can incorporate as few as four deployable prisms 320, but a larger number of prisms 320 would likely provide the user with an ideal number of electrodes 150 and electrode spacing for effective treatment.

[0097] In this embodiment, as in other embodiments, markers are provided along the inner surface of the prism 320 to identify the position of the electrodes 150 along the prism 320 under visualization. This allows the user to determine which electrodes 150 are in contact with tissue and then instruct the energy supply module to supply energy to those selected electrodes 150. Furthermore, in one embodiment, the system may include image recognition software that analyzes a live image feed from the endoscope and identifies any electrode markers present. For example, if markers such as A1 and A2 are present, the image recognition module can identify these electrodes and provide the user with the option to confirm that the electrodes corresponding to markers A1 and A2 should be activated to supply energy to the user.

[0098] This image recognition function can be implemented in any of the other embodiments described herein, in which electrode markers are present and a proposed electrode activation plan is provided to the user.

[0099] Balloon with PFA braided wire mesh electrode array Figure 9 shows a balloon catheter 400 similar to other balloon catheters described herein. Consequently, the reference numerals used in Figure 4 are also used in Figure 9 for parts common to both embodiments.

[0100] The balloon catheter 400 includes a main catheter shaft 110, which typically includes more than one shaft, often including an inner catheter shaft and an outer catheter shaft, or otherwise including multiple concentric tubular structures. The inflatable balloon 120 is included in and coupled to the main catheter shaft 110, with the distal end of the inflatable balloon 120 close to the distal end of the main catheter shaft 110, and the proximal end of the inflatable balloon 120 spaced away from the distal end. Thus, the inflatable balloon 120 surrounds the main catheter shaft 110.

[0101] The balloon catheter 400 includes a wire braid 410, which is positioned on an inflatable balloon 120 and is configured to stretch radially as the inflatable balloon 120 inflates. The wire braid 410 may include a wire mesh braid as shown in the figure. This wire mesh can be used as a support structure for an electrode array formed by electrodes 150 and can be made of an insulating material. The electrodes 150 are positioned along the outer surface of the wire braid 410, and the covering of the electrodes 150 may be uniform or non-uniform. In a non-uniform embodiment, the electrodes 150 can be more concentrated in one or more regions of the wire braid 410. For example, the electrodes 150 can be primarily positioned in the central region of the wire braid 410 where tissue contact is more likely to occur.

[0102] Furthermore, the spacing between electrodes can be the same along the entire electrode array, or it can be different in one or more regions of the wire braid 410. For example, in the central region of the wire braid 410, the spacing can be closer to each other.

[0103] As in other embodiments, the electrode 150 is connected to an energy source using conventional electrical traces or wiring (conductive paths) associated with and / or incorporated into the braided wire.

[0104] Alternatively, by incorporating an insulating coating onto a conductive (metallic) braided wire and stripping it at desired locations for energy supply (by defining discrete electrodes in the areas where the coating is removed), the wire braid 410 (support structure) itself can function as and define an electrode array. The wire braid 410 is operably connected to an energy source, and current (energy) is supplied throughout the wire braid 410, with the areas where the insulating coating is removed defining electrodes that define the electrode array.

[0105] A wire mesh braid can be formed with separate discrete insulated wires to define discrete paths, along which electrodes can be placed. By defining discrete electrode paths, discrete regions of the wire mesh braid can be activated without activating other regions, enabling the activation of those electrodes or electrode regions in contact with tissue.

[0106] As shown in the illustration, the wire braid 410 can extend beyond the inflatable balloon 130, with one end of the wire braid 410 extending proximal to the inflatable balloon 130 and the other end of the wire braid 410 extending distally to the inflatable balloon 130.

[0107] As with other embodiments, this embodiment again uses an endoscope inside the balloon 130 to confirm electrode placement and tissue contact. The number of electrodes 150 in the array may vary along with the number of braided wires to achieve the clinically most effective energy delivery, and the user may be able to select or deselect the number of electrodes to customize the treatment zone.

[0108] Balloon with implantable electrode array Figure 10 shows a balloon catheter 500 including a main catheter shaft 110 together with an inflatable balloon 510, the inflatable balloon 510 being coupled to and extending along the main catheter shaft 110, as in other embodiments. The distal end of the inflatable balloon 510 is coupled to the distal end of the main catheter shaft 110, and the proximal end of the inflatable balloon 510 is coupled to the main catheter shaft 110 at a position spaced apart from the distal end of the main catheter shaft 110.

[0109] The inflatable balloon 510 is a compliant balloon with an integrated electrode 150. The balloon 510 itself includes a flexible wire trace 151 and the electrode 150 embedded in the balloon material.

[0110] In this embodiment, the electrodes 150 can be positioned inside and integrated with the balloon 510 as part of the balloon 510 molding process. The electrodes 150 are spaced apart throughout the balloon 510 in a desired pattern. For example, the electrodes 150 are arranged circumferentially around the balloon 510. Alternatively, instead of positioning and attaching the electrodes 150 to the balloon material during the manufacturing process, they can be attached to the balloon 510 after the manufacturing process. In particular, the electrodes 150 can be attached to the outer surface of the balloon 510, and in this case, the traces 151 can also be attached to the outer surface of the balloon 510. These elements can be attached to the outside of the balloon 510 using any number of conventional techniques, such as using adhesives, binders, etc.

[0111] The electrodes 150 are formed such that the outer surface of each electrode 150 is exposed along the surface of the balloon 150 in order to be positioned in contact with the tissue. Each flexible trace 151 is formed in a zigzag pattern, which is intended to allow the flexible trace 151 to move with the compliant balloon during inflation / deflation and positioning against the tissue. In other words, this zigzag pattern accommodates the flexible trace 151 during balloon expansion and contraction and prevents damage to the trace(s). Each flexible trace 151 is operably coupled to an energy source so that it can supply energy to a selected electrode 150.

[0112] As with other embodiments, this embodiment again uses an endoscope inside the balloon 510 to confirm the placement of electrodes and tissue contact. Once the user has determined which electrodes 150 are in contact with the tissue, the user can select these electrodes for activation.

[0113] Furthermore, as in other embodiments, electrode markers visible inside the balloon 510 from the endoscope are provided, allowing the user or image recognition software to determine which electrodes are clearly visible within the endoscope's field of view. Based on this information, energy is supplied to the selected electrode 150 to form damage. The user interface can be configured to make it easy for the user to select which electrode to supply energy to. For example, an electrode map could be presented to the user on a touchscreen, and / or image recognition software could pre-provide a proposed electrode activation map on the screen, which would indicate which electrodes are visible in the endoscope and in contact with tissue.

[0114] Balloon with micropores and internal electrode array Figures 11 and 12 show a balloon catheter 600 including a main catheter shaft 110 together with an inflatable compliant balloon 610, the compliant balloon 610 being coupled to and extending along the main catheter shaft 110. An outer catheter body or sleeve 115 is also present, and as mentioned, the catheter 600 may include other shafts, such as an outer catheter shaft and an inner catheter shaft. The distal end of the inflatable balloon 610 is coupled to the distal end of the main catheter shaft 110, and the proximal end of the balloon 610 is coupled to the main catheter shaft 110 at a position spaced apart from the distal end.

[0115] As in other embodiments, the endoscope may be located inside the balloon 610 and coupled to the main catheter shaft 110. The endoscope is facing forward, allowing observation of the transparent balloon 610 and its contact with the surrounding tissue.

[0116] According to this embodiment, at least a portion of the balloon 610 has micropores 611 formed therein. Preferably, the micropores 611 are formed in one or more regions of the balloon 610 where energy is supplied to the tissue. In the illustrated embodiment, the proximal and distal ends of the balloon 610 do not have micropores 611, but the central region is the one that comes into contact with the tissue during use, and this central region contains micropores 611.

[0117] For simplicity, the micropores 611 in Figure 12 are shown to have larger dimensions than the micropores in Figure 11. However, it will be understood that the micropores in Figures 11 and 12 can be the same size and number. However, Figure 12 conveys that the micropores 611 can be formed to have different sizes and even different shapes.

[0118] The micropores 611 may have a uniform configuration (i.e., the same size and shape), or there may be two or more types of micropores 611. The micropores 611 may be formed in a uniform pattern as shown, or in a non-uniform pattern. For example, as shown, the micropores 611 may be formed in a circumferential grid pattern around the entire balloon 610.

[0119] The balloon catheter 600 also includes an electrode carrier 620 positioned within the balloon and, in at least one embodiment, capable of moving within the balloon 610 (i.e., rotating within the balloon 610 and / or moving longitudinally within the balloon 610). The electrode carrier 620 includes one or more electrodes 622 housed within a housing (hood) 624. In the illustrated embodiment, there is a pair of electrodes 622 within the housing 624 (however, it is possible to use a single electrode within the hood, in which case the hood rotates inside the porous balloon). The housing 624 functions to contain and direct the energy of the electrodes 622. The electrodes 622 are positioned close to the balloon itself, and the housing itself is positioned in direct contact with the inner surface of the balloon. The hood 624 can optimize the rate of ablation energy delivered to the tissue. However, the hood 624 can be excluded and is not necessarily required.

[0120] Therefore, the electrode array 622 is housed within a housing 624, which also serves to encapsulate a conductive liquid medium such as saline (e.g., physiological saline or hypertonic saline), allowing energy to flow directly into the tissue through the micropores 611. In other words, the conductive liquid medium can be supplied to the housing 624, for example, by using one or more conduits 626 that open into the interior of the housing 624. When the electrodes 622 are activated, energy is generated by the electrodes (e.g., between the electrodes), and since the electrodes 622 are immersed in the conductive liquid medium, the energy helps to heat the conductive liquid medium. The presence of the micropores 611 allows the heated conductive liquid medium to seep into the tissue through the micropores 611, and as a result, combined with the energy from the electrodes 622 transmitted throughout the balloon material, target damage is formed. In particular, damaged segments are formed. To form complete damage, the electrode carrier 620 can be rotated and / or moved along the inner surface of the balloon. The electrode carrier 620 is held in contact with the inner surface of the balloon 610 using user-controlled mechanical adjustments or using a secondary balloon that the user can inflate or deflate to adjust the electrode contact pressure.

[0121] The combination of the electrode array and the conductive liquid medium defines the conductive paths used to form the damaged segments. It will be understood that the inflation medium for controlling the inflation or deflation of balloon 610 may be the same as, or different from, the conductive liquid medium supplied to the inside of housing 624.

[0122] In yet another embodiment, the balloon 610 does not contain micropores 611 and is instead formed of a conductive balloon material (e.g., a balloon material doped with carbon nanotubes). In this alternative embodiment, the housing (hood) can be eliminated or retained. Thus, a non-conductive fluid can be used inside the balloon. The electrode array (or single electrode) is still located inside the balloon 610 and is movable therein, for example, it can rotate freely within the balloon and / or move longitudinally. Thus, the energy supplied to the electrode array is transferred to a local area of ​​the conductive balloon adjacent to the electrode array to form damage. In other words, the electrode array faces a local area of ​​the balloon, and the energy supplied to the electrode array is transferred to this local area of ​​the balloon to form damage.

[0123] Referring here to Figure 13, in yet another embodiment, a porous balloon catheter 700 is shown. The porous balloon catheter 700 is similar to the balloon catheter 600, and therefore similar elements are numbered similarly. Thus, the balloon contains micropores 611. The balloon catheter 700 includes an elongated structure 710, which may be similar to the elongated structure 1 in Figure 1, instead of an electrode carrier 620, but with some notable differences, the elongated structure 710 is located inside the balloon rather than outside the balloon as in Figure 1. The elongated structure 710 comprises a first tubular portion 712 and a second tubular portion 714 surrounding the catheter shaft. The elongated structure 710 is multi-branched into two or more, preferably six or more branches 720, each branch 720 containing one or more electrodes 715 on its outward-facing surface. The elongated structure 710 can be made of an elastic material pre-formed into a geometric shape that allows it to stretch as the balloon inflates and remain in contact with the inner surface of the balloon. The elongated structure 710 will be deflated by the balloon as the balloon deflates by removing the liquid from the balloon under vacuum. In other words, as the balloon expands, the elongated structure automatically and naturally expands, and is constructed to similarly contract with the balloon's contraction. This can happen naturally due to the memory properties of the elongated structure 710. Thus, the electrode 715 on the outer surface of the elongated structure 710 is in contact with the inner surface of the porous balloon. As in other embodiments, the balloon contains a conductive fluid passing through micropores. Thus, energy from the electrode 715 is transferred throughout the balloon itself, and / or the conductive fluid within the balloon passes through the micropores to reach the target tissue.

[0124] In all embodiments, it will be understood that electrodes are connected to a controllable energy source using conventional techniques, including electrical leads, wiring, and conductive paths. The energy source can be controlled using conventional control devices such as a master controller. This master controller may be part of a console from which the user can register inputs and control and select various operating parameters, such as administration information (e.g., administration power (wattage)).

[0125] These embodiments incorporating electrode arrays are particularly well-suited for supplying electroporation ablation energy (PFA).

[0126] Additional details relating to specific embodiments of this disclosure are as follows:

[0127] A device for modifying tissue, particularly for altering the conductive properties of the tissue, in order to achieve a desired result.

[0128] An external sheath placed on an existing catheter system.

[0129] It consists of three distinctive parts: a rigid position collar at the distal end, a softer, more flexible balloon-stretchable section (or alternative configuration) located near the primary balloon, and an overcoat of the catheter body extending near the proximal end.

[0130] The electrodes may be placed in a rigid color section to measure distal electrical activity, or they may be used for energy supply.

[0131] The electrodes are primarily positioned in the expandable section of the balloon and are intended to supply energy to achieve modification of the properties of the target tissue in various configurations (in other sections).

[0132] The main body's overcoat incorporates conductors for distal measurement and energy supply, and is terminated near the control unit for replacement with other energy sources.

[0133] The electrodes on the color may be configured in various ways, including 2, 4, or 6 style square electrodes spaced equally apart around the measurement range on the color.

[0134] The electrodes within the balloon's expandable range are intended to provide the primary energy supply (for therapeutic purposes) to the device. The most likely embodiment is an arc-shaped arrangement of 16 electrodes positioned equally spaced proximal to the primary therapeutic range and (not necessarily, but likely) in the same location as where the primary energy is supplied or supplied, with the balloon slightly deflated to allow the electrode array to extend distally to the therapeutic range. This alignment ensures that the electrodes are equally spaced and separated at the inflation pressure specified for "PFA" therapy, resulting in access to the electrodes individually or in various groups.

[0135] To avoid any influence on the bending or rotation of the primary catheter, or to have at least a minimal influence, the catheter overcoat will have conductive means for all sensing electrodes and energy supply electrodes (some or all of which serve a dual purpose). This may be a helical routing that has the capability to use various helical pitches.

[0136] The balloon-stretchable section of the device may be a complete sheath made of a highly elastic material with electrodes on its surface, or it may be more rigid by removing a section of the device so that the electrodes are positioned within a desired range by displacement of the structure.

[0137] Similar numbering in the drawings represents similar elements across several drawings, and it should be understood that not all components and / or processes described and illustrated with reference to the drawings are required for all embodiments or configurations.

[0138] The terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit the invention. Where used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form unless otherwise clearly indicated by the context. The terms “comprises” and / or “comprising,” when used herein, specify the presence of the described features, integers, processes, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, processes, operations, elements, components, and / or groups thereof.

[0139] Furthermore, the expressions and terms used herein are for illustrative purposes only and should not be considered limiting. The use of “including,” “comprising,” “having,” “containing,” “involving,” and variations thereof herein means to include the items listed therein and their equivalents, as well as any additional items.

[0140] The subject matter described above is provided for illustrative purposes only and should not be construed as limiting. Various modifications and changes to the subject matter described herein can be made without following the examples and embodiments and applications described herein, and without departing from the true spirit and scope of the invention as set forth in the following claims.

Claims

1. It is an ablation catheter system, A balloon ablation catheter including an inflatable balloon attached to a shaft, A longitudinally displaceable sleeve configured to move longitudinally along the balloon ablation catheter, the longitudinally displaceable sleeve having a proximal end portion, an opposite distal end portion, and a plurality of branches connected to both the proximal end portion and the distal end portion, the balloon ablation catheter having a longitudinally displaceable sleeve that moves between a first position in which the longitudinally displaceable sleeve is positioned more proximal to the inflatable balloon and a second position in which the longitudinally displaceable sleeve is positioned more distal to the inflatable balloon, It is an ablation catheter system equipped with, At least one branch includes at least one electrode arranged along its outer surface, An ablation catheter system in which the multiple branches are configured to unfold and extend radially under the inflation of the inflatable balloon.

2. The ablation catheter system according to claim 1, wherein the first position is such that the longitudinally displaceable sleeve is positioned proximal to the balloon, and the second position is such that the longitudinally displaceable sleeve covers at least 50% of the inflatable balloon.

3. The ablation catheter system according to claim 1, wherein the proximal end portion of the longitudinally displaceable sleeve comprises a first tubular structure, the distal end portion of the longitudinally displaceable sleeve comprises a second tubular structure, the first end of the plurality of branches is connected to the first tubular structure, and the second end of the plurality of branches is connected to the second tubular structure.

4. The ablation catheter system according to claim 1, wherein the proximal end portion, the plurality of branches, and the distal end portion are formed as a single, integrated component.

5. The ablation catheter system according to claim 1, wherein a plurality of longitudinal slits are formed between the plurality of branches, thereby allowing radial extension of the plurality of branches under inflation of the inflatable balloon.

6. The ablation catheter system according to claim 5, wherein the width of each longitudinal slit is different from the width of each branch.

7. The ablation catheter system according to claim 1, wherein the longitudinally displaceable sleeve is formed of a material selected from the group consisting of polyimide film, polyester film, and urethane film.

8. The ablation catheter system according to claim 1, wherein the first position is a retracted position, and the second position is an extended position in which the plurality of branches are positioned on the inflatable balloon.

9. The ablation catheter system according to claim 1, wherein, at the first position, each of the first tubular structure, the plurality of branches, and the second tubular structure is positioned proximal to the inflatable balloon.

10. The ablation catheter system according to claim 1, wherein, in the second position, the second tubular structure is positioned distal to the inflatable balloon and on the distal end of the shaft, and the first tubular structure is positioned proximal to the inflatable balloon and on the shaft.

11. The ablation catheter system according to claim 1, wherein the lengths of the plurality of branches are greater than the lengths of the first tubular structure and the second tubular structure, respectively.

12. The ablation catheter system according to claim 11, wherein the length of the first tubular structure is greater than the length of the second tubular structure.

13. The ablation catheter system according to claim 1, wherein each of the plurality of branches includes at least one electrode.

14. The ablation catheter system according to claim 13, wherein each of the plurality of branches includes two or more electrodes.

15. The ablation catheter system according to claim 14, wherein two or more electrodes of each branch are spaced apart in the longitudinal direction.

16. The ablation catheter system according to claim 1, further comprising a main controller operably connected to each electrode to enable control of each electrode.

17. The ablation catheter system according to claim 16, wherein in the first operating mode, all of the electrodes are activated by the main controller, and in the second operating mode, fewer than all of the electrodes are activated.

18. The ablation catheter system according to claim 1, wherein the plurality of branches are arranged in the circumferential direction.

19. The ablation catheter system according to claim 1, wherein each electrode is connected to an insulated wire embedded in the body of the longitudinally displaceable sleeve.

20. The ablation catheter system according to claim 1, wherein each branch is formed of a material that allows the branch to lengthen longitudinally when a radially outward force is applied by the inflation of the inflatable balloon.

21. The ablation catheter system according to claim 1, further comprising an endoscope, wherein the longitudinally displaceable sleeve includes a plurality of electrode markers formed along the inner surface of the longitudinally displaceable sleeve, the at least one electrode comprises a plurality of electrodes arranged along the outer surface of the longitudinally displaceable sleeve, the plurality of electrode markers are formed on opposite sides of the plurality of electrodes to identify the positions of the plurality of electrodes, and the plurality of electrode markers are visible from the endoscope.

22. The ablation catheter system according to claim 21, further comprising a display showing an image of the longitudinally displaceable sleeve, and provided with a graphical user interface that allows the user to select which of the plurality of electrodes to activate.

23. The ablation catheter system according to claim 1, wherein the longitudinally displaceable sleeve comprises a tubular structure having longitudinal slits formed therein, and the plurality of branches are defined between the longitudinal slits.

24. The ablation catheter system according to claim 1, wherein the proximal end portion comprises a partial circumferential section, while the distal end portion comprises a complete circumferential portion.

25. The ablation catheter system according to claim 24, wherein the proximal end portion includes a complete circumferential section to which the plurality of branches are attached, and the partial circumferential section is located proximal to the complete circumferential section.

26. It is an ablation catheter system, A balloon ablation catheter comprising an inflatable porous balloon coupled to a catheter shaft, wherein a plurality of micropores are formed within at least a first region of the inflatable porous balloon, At least one electrode movably disposed inside the inflatable porous balloon, An ablation catheter system equipped with [features / equipment].

27. The ablation catheter system according to claim 26, wherein the at least one electrode is located in and supported within a movable hood rotatably coupled to the catheter shaft and is configured to be positioned relative to the inner surface of the inflatable porous balloon.

28. The ablation catheter system according to claim 27, wherein the hood includes at least one fluid conduit that is in fluid communication with the inside of the hood in order to supply a conductive fluid into the inside of the hood, thereby facilitating the passage of the conductive fluid through the micropores.

29. The ablation catheter system according to claim 28, wherein the at least one fluid conduit comprises a lumen formed in a tubular support attached to the hood at its distal end.

30. The ablation catheter system according to claim 26, wherein the first region is the central region of the inflatable porous balloon located between the proximal and distal regions, and neither the proximal nor the distal region has a hole.

31. The ablation catheter system according to claim 26, wherein the at least one electrode is rotatably coupled to the catheter shaft of the balloon ablation catheter and is movable in both radial directions toward and away from the catheter shaft.

32. The ablation catheter system according to claim 26, wherein the at least one electrode is supported by an electrode sleeve, the electrode sleeve is made of an elastic material and is placed inside the inflatable porous balloon, the electrode sleeve has a proximal end portion, an opposite distal end portion, and a plurality of branches connected to both the proximal end portion and the distal end portion, and the at least one electrode comprises an electrode array arranged along the outside of one or more of the plurality of branches and is configured to be positioned relative to the inner surface of the porous balloon.

33. The ablation catheter system according to claim 32, wherein the elastic electrode sleeve is pre-formed such that, in a resting position, the plurality of branches expand radially and extend radially outward relative to the catheter shaft, and the plurality of branches are configured such that, when the porous balloon is in a contracted state, the plurality of branches are retracted and move radially inward toward the catheter shaft.

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